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FDA 510(k)

RNA MEDICAL HEMAT CONTROL

K-Number: K955630 · 1996-03-01

ApplicantBionostics, Inc.
Decision Date1996-03-01
Product CodeJJR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RNA MEDICAL HEMAT CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 1996-03-01 under 510(k) number K955630. The device is classified under product code JJR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RNA MEDICAL HEMAT CONTROL?

RNA MEDICAL HEMAT CONTROL is a medical device that received FDA 510(k) clearance on 1996-03-01. The listed applicant is Bionostics, Inc.. The 510(k) number is K955630.

When did RNA MEDICAL HEMAT CONTROL receive FDA 510(k) clearance?

RNA MEDICAL HEMAT CONTROL received FDA 510(k) clearance on 1996-03-01, under 510(k) number K955630.

Who is the listed applicant for RNA MEDICAL HEMAT CONTROL?

The FDA 510(k) record lists Bionostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RNA MEDICAL HEMAT CONTROL?

The FDA product code for RNA MEDICAL HEMAT CONTROL is JJR.

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Related Devices (Code: JJR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K990971EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816Medica Corp.K960592ELECTROLYTE STANDARDSPhoenix Diagnostics, Inc.K951435AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIALAalto Scientific, Ltd.K943925SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTINGQuantimetrix Corp.K934641I-STAT CONTROL LEVELS 1,2,3I-Stat Corp.K912513ELECTROLYTE CONTROLVerichem Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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